APPLICATION
ANDA073459
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
2002-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CLEMASTINE FUMARATEDiscontinued
CLEMASTINE FUMARATE 2.68MG · TABLET · ORAL
Approval history
2002-12-16Manufacturing (CMC) · Supplement 11AP
2002-05-13Manufacturing (CMC) · Supplement 10AP
2001-09-04Manufacturing (CMC) · Supplement 5AP
2001-08-07Manufacturing (CMC) · Supplement 9AP
2001-01-02Manufacturing (CMC) · Supplement 8AP
2000-12-29Manufacturing (CMC) · Supplement 7AP
2000-11-30Manufacturing (CMC) · Supplement 6AP
1999-05-05Manufacturing (CMC) · Supplement 3AP
1998-03-27Manufacturing (CMC) · Supplement 2AP
1997-08-15Manufacturing (CMC) · Supplement 1AP
1993-10-31OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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